New study peers inside the heart and kidneys of people with type 1 diabetes
NCT ID NCT07270172
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This observational study will use special PET scans to measure how much oxygen the heart and kidneys use in people with type 1 diabetes. Researchers want to see if a more intensive treatment plan (multifactorial intervention) lowers oxygen demand compared to standard care. Forty adults with type 1 diabetes and signs of kidney or heart disease will be followed for two years.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population for the Steno1 Study is persons with Type 1 Diabetes at the Steno Diabetes Centre and at partner clinics in Region Midt, Denmark. The MICRON study will recruit from these participants.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Steno 1 inclusion criteria: * Male or female persons ≥40 years old with T1D (diagnosis before age 30 with insulin from onset or if diagnosis after 30 years of age insulin from onset and DKA or positive autoantibodies (in accordance with local guidelines), or confirmed, at the investigator's discretion by the available medical records) during \>10 years. * Presence of chronic kidney disease (UACR \>30 mg/g or eGFR \< 60 ml/min/1.73 m2) OR history of ischemic heart disease (previous myocardial infarction, stroke or angina) OR history of heart failure OR obesity grade 2 and 3 (BMI\>35 kg/m2) OR 5-year CVD risk \>10% according to Steno Type 1 Risk Engine. * Fertile females must use highly efficient chemical, hormonal and mechanical contraceptives during the whole study and at least 2 months after cessation of study drug. The following contraceptive methods are approved: IUD or hormonal contraception that inhibits ovulation, i.e. pills, implantations, transdermal patches, vaginal ring or depot injection. Alternatively, be in menopause (i.e. must not have had regular menstrual bleeding for at least one year), have undergone bilateral oophorectomy or have been surgically sterilized or hysterectomised at least 12 months prior to screening. * Ability to communicate with the investigator and understand informed consent. * Given written informed consent. Steno 1 exclusion criteria: * Type 2 Diabetes, Maturity-onset diabetes of the young (MODY), secondary diabetes. * History of pancreatitis. * Body mass index \< 18.5 kg/m2 * Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods. * Known or suspected abuse of alcohol or recreational drugs. * Participant in another drug-intervention study. * Chronic Kidney Disease stage 5. Additional exclusion criteria in the MICRON study: * Active malignant disease * Use of study drugs (SGLT inhibitors, GLP-1 RA, or finererone) at inclusion.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aarhus University Hospital
RECRUITINGAarhus N, 8200, Denmark
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Regionshospitalet Gødstrup
RECRUITINGGødstrup, 7400, Denmark
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Regionshospitalet Horsens
RECRUITINGHorsens, 8700, Denmark
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Regionshospitalet Silkeborg
RECRUITINGSilkeborg, 8600, Denmark
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Regionshospitalet Vibrg
RECRUITINGViborg, 8800, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gene therapy aims to free type 1 diabetics from insulin shots
- Muscle-Injected gene therapy aims to help type 1 diabetes control blood sugar
- Can a glucose sensor and family coaching tame type 1 diabetes in toddlers?
- Can a smartphone app help heal diabetic foot wounds?
- Can a handoff plan help teens with chronic illness take charge of their care?
- Cheap blood test could flag diabetic kidney damage before it strikes